[Federal Register Volume 63, Number 148 (Monday, August 3, 1998)]
[Rules and Regulations]
[Pages 41189-41190]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-20597]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520


Oral Dosage Form New Animal Drugs; Milbemycin Oxime/Lufenuron 
Tablets

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is amending the animal 
drug regulations to reflect approval of a supplemental new animal drug 
application (NADA) filed by Novartis Animal Health US, Inc. The 
supplemental NADA provides for use of a milbemycin oxime/lufenuron 
flavored tablet formulation for dogs not less than 4 weeks of age and 
not less than 11 pounds of body weight for prevention of heartworm 
disease, for prevention and control of flea populations, for control of 
hookworm, and for removal and control of roundworms and whipworms.

EFFECTIVE DATE: August 3, 1998.
FOR FURTHER INFORMATION CONTACT: Melanie R. Berson, Center for 
Veterinary Medicine (HFV-110), Food and Drug Administration, 7500 
Standish Pl., Rockville, MD 20855, 301-594-1612.

SUPPLEMENTARY INFORMATION: Novartis Animal Health US, Inc., P.O. Box 
18300, Greensboro, NC 27419-8300, filed supplemental NADA 141-084 that 
provides for veterinary prescription use of SentinelTM 
(milbemycin oxime/lufenuron) flavor tablets (5.75 and 115 milligrams 
(mg), 11.5 and 230 mg, and 23 and 460 mg) for dogs not less than 4 
weeks of age and not less than 11 pounds of body weight. The tablets 
are used for the prevention of heartworm disease, for prevention and 
control of flea populations, for control of adult hookworm, and removal 
and control of adult roundworm and whipworm infections when used at a 
minimum dosage of 0.5 milligram/kilogram of body weight (mg/kg) 
milbemycin with a minimum of 10 mg/kg lufenuron. The supplement is 
approved as of June 17, 1998. To reflect the approval, FDA is 
redesignating 21 CFR 520.1446(c) as paragraph (d), reserving paragraph 
(c), and revising newly redesignated paragraph (d). The basis of 
approval is discussed in the freedom of information summary.
     In accordance with the freedom of information provisions of 21 CFR 
part 20 and 514.11(e)(2)(ii), a summary of safety and effectiveness 
data and information submitted to support approval of this application 
may be seen

[[Page 41190]]

in the Dockets Management Branch (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852, 
between 9 a.m. and 4 p.m., Monday through Friday.
    Under 21 U.S.C. 360b(c)(2)(F)(iii), this supplemental approval for 
non-food producing animals qualifies for 3 years of marketing 
exclusivity for the new formulation beginning June 17, 1998, because 
the supplemental application contains substantial evidence of 
effectiveness of the drug involved or any studies of animal safety 
required for the approval of the supplement and conducted or sponsored 
by the applicant. The 3 years of marketing exclusivity applies only to 
use of the new milbemycin oxime/lufenuron flavored tablets in three 
tablet sizes.
    FDA has determined under 21 CFR 25.33(d)(1) that this action is of 
a type that does not individually or cumulatively have a significant 
effect on the human environment. Therefore, neither an environmental 
assessment nor an environmental impact statement is required.

List of Subjects in 21 CFR Part 520

    Animal drugs.
    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs and 
redelegated to the Center for Veterinary Medicine, 21 CFR part 520 is 
amended as follows:

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

    1. The authority citation for 21 CFR part 520 continues to read as 
follows:

    Authority: 21 U.S.C. 360b.

    2. Section 520.1446 is amended by redesignating paragraph (c) as 
paragraph (d), by reserving paragraph (c), and by revising newly 
redesignated paragraph (d), to read as follows:

Sec. 520.1446   Milbemycin oxime/lufenuron tablets.

* * * * *
    (c) [Reserved]
    (d) Conditions of use-- (1) Dogs-- (i) Amount. 0.5 milligrams of 
milbemycin and 10 milligrams of lufenuron per kilogram of body weight.
    (ii) Indications for use. For use in dogs and puppies for the 
prevention of heartworm disease caused by Dirofilaria immitis, for 
prevention and control of flea populations, control of adult 
Ancylostoma caninum (hookworm), and removal and control of adult 
Toxocara canis, Toxascaris leonina (roundworm), and Trichuris vulpis 
(whipworm) infections. Lufenuron controls flea populations by 
preventing the development of flea eggs and does not kill adult fleas. 
Concurrent use of insecticides may be necessary for adequate control of 
adult fleas.
    (iii) Limitations. Administer tablets once a month, preferably on 
the same date each time. All dogs in a household should be treated to 
achieve maximum efficacy. Do not use in dogs less than 4 weeks of age 
and less than 2 pounds body weight. Federal law restricts this drug to 
use by or on the order of a licensed veterinarian.
    (2) [Reserved]

    Dated: July 14, 1998.
Margaret Ann Miller,
Acting Director, Office of New Animal Drug Evaluation, Center for 
Veterinary Medicine.
[FR Doc. 98-20597 Filed 7-31-98 ; 8:45 am]
BILLING CODE 4160-01-F